HeartWare Ventricular Assist System,

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    SATP

3 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: HeartWare Ventricular Assist System, Controller
  • Manufacturer
  • Model / Serial
    1650, 1650DE | All HeartWare Battery Serial Numbers
  • Product Description
    AIMD: Artificial heart, temporary
  • Manufacturer
  • Model / Serial
    HeartWare Sterile Surgical Tool Sets (Supplied as part of the HeartWare Ventricular Assist System, artifical heart (HVAS))Catalogue Number: 1318Lot Number: 520863ARTG Number: 181875
  • Manufacturer